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| United States Patent |
6,162,443
|
|
Flament-Garcia
, et al.
|
December 19, 2000
|
Container for an inhalation anesthetic
Abstract
A pharmaceutical product. The pharmaceutical product includes a container
constructed from a material containing one or more of polypropylene,
polyethylene, and ionomeric resins. The container defines an interior
space. A volume of a fluoroether-containing inhalation anesthetic is
contained in the interior space defined by the container.
| Inventors:
|
Flament-Garcia; Mary Jane (Gurnee, IL);
Cromack; Keith R. (Lake Bluff, IL);
Loffredo; David (Elmhurst, IL);
Raghavan; Rajagopalan (Grayslake, IL);
Ramsay; George M. (Waukegan, IL);
Speicher; Earl R. (Buffalo Grove, IL)
|
| Assignee:
|
Abbott Laboratories (Abbott Park, IL)
|
| Appl. No.:
|
205460 |
| Filed:
|
December 4, 1998 |
| Current U.S. Class: |
424/400; 424/451 |
| Intern'l Class: |
A61K 009/48 |
| Field of Search: |
424/400,451
|
References Cited
U.S. Patent Documents
| 5114715 | May., 1992 | Young et al. | 424/400.
|
| 5303834 | Apr., 1994 | Krishnakumar et al. | 215/1.
|
| 5505236 | Apr., 1996 | Grabenkort et al. | 141/329.
|
| 5780130 | Jul., 1998 | Hansen et al. | 428/35.
|
| 5804016 | Sep., 1998 | Schmidt et al. | 156/242.
|
| Foreign Patent Documents |
| 0088056 | Sep., 1983 | EP.
| |
| 9832430 | Jul., 1998 | WO.
| |
Other References
Dessing J., Sprenger A., Kieviet O.S.: "Repertorium 94/95" (1994)
S-Gravenhage, SDU, The Hague XP002101345.
|
Primary Examiner: Clardy; S. Mark
Assistant Examiner: Shelborne; Kathryne E.
Attorney, Agent or Firm: Woodworth; Brian R.
Parent Case Text
This application is a continuation-in-part of U.S. Ser. No. 09/004,792
filed Jan. 9, 1998 and a continuation-in-part of U.S. Ser. No. 09/004,876
filed Jan. 9, 1998.
Claims
What is claimed is:
1. An inhalation anesthetic product comprising:
a container constructed from a material comprising a compound selected from
the group consisting of polypropylene, polyethylene, ionomeric resins, and
combinations thereof, said container defining an interior space
constructed to contain therein, external to a patient's body, an
inhalation anesthetic; and
a volume of sevoflurane contained in said interior space defined by said
container.
2. An inhalation anesthetic product in accordance with claim 1, wherein
said container defines an opening therein, said opening providing fluid
communication between said interior space defined by said container and an
external environment of said container, said inhalation anesthetic product
further comprising a cap, said cap constructed to seal said opening
defined in said container, said cap comprising a material comprising a
compound selected from the group consisting of polypropylene,
polyethylene, polyethylene napthalate, polymethylpentene, ionomeric
resins, and combinations thereof.
3. An inhalation anesthetic product in accordance with claim 1, wherein
said container defines an opening therein, said opening providing fluid
communication between said interior space defined by said container and an
external environment of said container, said inhalation anesthetic product
further comprising a cap having an interior surface, said cap constructed
to seal said opening defined in said container, said interior surface of
said cap constructed from a material comprising a compound selected from a
group consisting of polypropylene, polyethylene, polyethylene napthalate,
polymethylpentene, ionomeric resins, and combinations thereof.
4. An inhalation anesthetic product comprising:
a container defining an interior space constructed to contain therein.
external to a patient's body. an inhalation anesthetic, said container
having an interior surface adjacent to said interior space, said interior
surface constructed from a material comprising a compound selected from a
group consisting of polypropylene, polyethylene, ionomeric resins, and
combinations thereof; and
a volume of sevoflurane contained in said container.
5. An inhalation anesthetic product in accordance with claim 4, wherein
said container defines an opening therein, said opening providing fluid
communication between said interior space defined by said container and an
external environment of said container, said inhalation anesthetic product
further comprising a cap, said cap constructed to seal said opening
defined in said container, said cap constructed from a material comprising
a compound selected from a group consisting of polypropylene,
polyethylene, polyethylene napthalate, polymethylpentene, ionomeric
resins, and combinations thereof.
6. An inhalation anesthetic product in accordance with claim 4, wherein
said container defines an opening therein, said opening providing fluid
communication between said interior space defined by said container and an
external environment of said container, said inhalation anesthetic product
further comprising a cap having an interior surface, said cap constructed
to seal said opening defined in said container, said interior surface of
said cap constructed from a material comprising a compound selected from a
group consisting of polypropylene, polyethylene, polyethylene napthalate,
polymethylpentene, ionomeric resins, and combinations thereof.
7. A method for storing an inhalation anesthetic external to a patient's
body, said method comprising the steps of:
providing a predetermined volume of sevoflurane;
providing a container defining an interior space, said container
constructed from a material comprising a compound selected from the group
consisting of polypropylene, polyethylene, ionomeric resins, and
combinations thereof; and
placing said predetermined volume of sevoflurane in said interior space
defined by said container.
8. A method for storing an inhalation anesthetic in accordance with claim
7, wherein said container defines an opening therein, said opening
providing fluid communication between said interior space defined by said
container and an external environment of said container, said method
further comprising the steps of:
providing a cap constructed to seal said opening defined in said container,
said cap constructed from a material comprising a compound selected from a
group consisting of polypropylene, polyethylene, polyethylene napthalate,
polymethylpentene, ionomeric resins, and combinations thereof; and
sealing said opening defined in said container with said cap.
9. A method for storing an inhalation anesthetic in accordance with claim
7, wherein said container defines an opening therein, said opening
providing fluid communication between said interior space defined in said
container and an external environment of said container, said method
further comprising the steps of:
providing a cap constructed to seal said opening defined in said container,
said cap having an interior surface constructed from a material comprising
a compound selected from a group consisting of polypropylene,
polyethylene, polyethylene napthalate, polymethylpentene, ionomeric
resins, and combinations thereof; and
sealing said opening defined in said container with said cap.
10. A method for storing an inhalation anesthetic external to a patient's
body, said method comprising the steps of:
providing a predetermined volume of sevoflurane;
providing a container defining an interior space, said container having an
interior wall adjacent said interior space defined by said container, said
interior wall of said container constructed from a material comprising a
compound selected from a group consisting of polypropylene, polyethylene,
ionomeric resins, and combinations thereof; and
placing said predetermined volume of sevoflurane in said interior space
defined by said container.
11. A method for storing an inhalation anesthetic in accordance with claim
10, wherein said container defines an opening therein, said opening
providing fluid communication between said interior space defined by said
container and an external environment of said container, said method
further comprising the steps of:
providing a cap constructed to seal said opening defined in said container,
said cap constructed of a material comprising a compound selected from a
group consisting of polypropylene, polyethylene, polyethylene napthalate,
polymethylpentene, ionomeric resins, and combinations thereof; and
sealing said opening defined in said container with said cap.
12. A method for storing an inhalation anesthetic in accordance with claim
10 wherein said container defines an opening therein, said opening
providing fluid communication between said interior space defined by said
container and an external environment of said container, said method
further comprising the steps of:
providing a cap constructed to seal said opening defined in said container,
said cap having an interior surface constructed from a material comprising
a compound selected from a group consisting of polypropylene,
polyethylene, polyethylene napthalate, polymethylpentene, ionomeric
resins, and combinations thereof; and
sealing said opening defined in said container with said cap.
13. An inhalation anesthetic product comprising:
a container constructed from a material comprising polypropylene, said
container defining an interior space constructed to contain therein,
external to a patient's body, an inhalation anesthetic; and
a volume of sevoflurane contained in said interior space defined by said
container.
14. An inhalation anesthetic product comprising:
a container constructed from a material comprising polyethylene, said
container defining an interior space constructed to contain therein,
external to a patient's body, an inhalation anesthetic; and
a volume of sevoflurane contained in said interior space defined by said
container.
15. An inhalation anesthetic product comprising:
a container constructed from a material comprising ionomeric resins, said
container defining an interior space constructed to contain therein,
external to a patient's body, an inhalation anesthetic; and
a volume of sevoflurane contained in said interior space defined by said
container.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a container for an inhalation anesthetic
and a method for storing an inhalation anesthetic. In particular, the
present invention is directed to a container constructed from a material
that provides a barrier to vapor transmission through a wall of the
container and that is non-reactive with an inhalation anesthetic contained
therein.
Fluoroether inhalation anesthetic agents such as sevoflurane
(fluoromethyl-2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether), enflurane
(2-chloro-1,1,2-trifluoroethyl difluoromethyl ether), isoflurane
(1-chloro-2,2,2-trifluoroethyl difluoromethyl ether), methoxyflurane
(2,2-dichloro-1,1-difluoroethyl methyl ether) and desflurane
(2-difluoromethyl 1,2,2,2-tetrafluoroethyl ether) are typically
distributed in containers constructed of glass. Although these fluoroether
agents have been shown to be excellent anesthetic agents, it has been
found that under certain conditions the fluoroether agent and the glass
container may interact, thereby facilitating degradation of the
fluoroether agent. This interaction is believed to result from the
presence of Lewis acids in the glass container material. Lewis acids have
an empty orbital which can accept an unshared pair of electrons and
thereby provide a potential site for reaction with the alpha fluoroether
moiety (--C--O--C--F) of the fluoroether agent. Degradation of these
fluoroether agents in the presence of a Lewis acid may result in the
production of degradation products such as hydrofluoric acid.
The glass material currently used to contain these fluoroether agents is
referred to as Type III glass. This material contains silicon dioxide,
calcium hydroxide, sodium hydroxide and aluminum oxide. Type III glass
provides a barrier to the transmission of vapor through the wall of the
container, thereby preventing the transmission of the fluoroether agent
therethrough and preventing the transmission of other vapors into the
container. However, the aluminum oxide contained in glass materials such
as type III glass tend to act as Lewis acids when exposed directly to the
fluoroether agent, thereby facilitating degradation of the fluoroether
agent. The degradation products produced by this degradation, e.g.,
hydrofluoric acid, may etch the interior surface of the glass container,
thereby exposing additional quantities of aluminum oxide to the
fluoroether compound and thereby facilitating further degradation of the
fluoroether compound. In some cases, the resulting degradation products
may compromise the structural integrity of the glass container.
Efforts have been made to inhibit the reactivity of glass to various
chemicals. For example, it has been found that treating glass with sulfur
will protect the glass material in some cases. However, it will be
appreciated that the presence of sulfur on the surface of a glass
container is not acceptable in many applications.
Furthermore, glass containers present a breakage concern. For example,
glass containers may break when dropped or otherwise subjected to a
sufficient force, either in use or during shipping and handling. Such
breakage can cause medical and incidental personnel to be exposed to the
contents of the glass container. In this regard, inhalation anesthetic
agents evaporate quickly. Thus, if the glass container contains an
inhalation anesthetic such as sevoflurane, breakage of the container may
necessitate evacuation of the area immediately surrounding the broken
container, e.g, an operating room or medical suite.
Efforts to address breakage concerns typically have involved coating the
exterior, non-product contact surfaces of the glass with polyvinyl
chloride (PVC) or synthetic thermoplastic resin such as Surlyn.RTM. (a
registered trademark of E. I. Du Pont De Nemours and Company). These
efforts increase the cost of the containers, are not aesthetically
pleasing, and do not overcome the above-discussed problems related to
degradation which can occur when using glass to contain
fluoroether-containing inhalation anesthetic agents.
For these reasons, it is desirable to provide a container constructed from
a material other than glass in order to store, transport, and dispense
inhalation anesthetics, thereby avoiding the above-discussed shortcomings
of glass. The preferred material does not contain Lewis acids which can
promote the degradation of the inhalation anesthetic agent, provides a
sufficient barrier to vapor transmission into and out of the container,
and increases the container's resistance to breakage relative to a glass
container.
SUMMARY OF THE INVENTION
The present invention is directed to a pharmaceutical product. The product
includes a container constructed from a material containing one or more of
polypropylene, polyethylene, and ionomeric resins. The container defines
an interior space in which a volume of a fluoroether-containing inhalation
anesthetic is contained.
In an alternative embodiment, the present invention is directed to a
pharmaceutical product in which a container defining an interior space has
an interior surface adjacent to the interior space. The interior surface
of the container is constructed from a material containing one or more of
polypropylene, polyethylene, and ionomeric resins. A volume of a
fluoroether-containing inhalation anesthetic is contained in the interior
space of the container.
The present invention is further directed to a method for storing an
inhalation anesthetic. The method includes the step of providing a
predetermined volume of a fluoroether-containing inhalation anesthetic. A
container also is provided, the container being constructed from a
material containing one or more of polypropylene, polyethylene, and
ionomeric resins. The container defines an interior space. The
predetermined volume of fluoroether-containing inhalation anesthetic is
placed in the interior space of the container.
In an alternative embodiment of the method of the present invention, a
predetermined volume of a fluoroether-containing inhalation anesthetic is
provided. In addition, a container having an interior surface defining an
interior space is provided. The interior surface of the container is
constructed from a material containing one or more of polypropylene,
polyethylene, and ionomeric resins. The predetermined volume of a
fluoroether-containing inhalation anesthetic is placed in the interior
space of the container.
BRIEF DESCRIPTION OF THE DRAWINGS
For a more complete understanding of the present invention, reference may
be had to the following Detailed Description read in connection with the
accompanying drawing in which:
FIG. 1 is cross-sectional view of a pharmaceutical product constructed in
accordance with the present invention.
DETAILED DESCRIPTION
A pharmaceutical product constructed in accordance with the present
invention is generally indicated at 10 of FIG. 1. Pharmaceutical product
10 includes container 12 having an interior surface 14. Interior surface
14 defines an interior space 16 within container 12. An inhalation
anesthetic 18 is contained within interior space 16 of container 12. In a
preferred embodiment of the present invention, inhalation anesthetic 18
contains a fluoroether compound. Fluoroether-containing inhalation
anesthetics useful in connection with the present invention include, but
are not necessarily limited to, sevoflurane, enflurane, isoflurane,
methoxyflurane, and desflurane. Inhalation anesthetic 18 is a fluid, and
may include a liquid phase, a vapor phases, or both liquid and vapor
phases. FIG. 1 depicts inhalation anesthetic 18 in a liquid phase.
The purpose of container 12 is to contain inhalation anesthetic 18. In the
embodiment of the present invention depicted in FIG. 1, container 12 is in
the shape of a bottle. However, it will be appreciated that container 12
can have a variety of configurations and volumes without departing from
the spirit and scope of the present invention. For example, container 12
can be configured as a shipping vessel for large volumes (e.g., tens or
hundreds of liters) of inhalation anesthetic 18. Such shipping vessels can
be rectangular, spherical, or oblong in cross-section without departing
from the intended scope of the invention.
Container 12 preferably is constructed of a material that minimizes the
amount of vapor transmission into and out of container 12, thereby
minimizing the amount of inhalation anesthetic 18 that is released from
interior space 16 of container 12 and thereby minimizing the amount of
vapor transmission, e.g., water vapor transmission, from an external
environment of container 12 into interior space 16 and thus into
inhalation anesthetic 18. Container 12 also is preferably constructed of a
material that does not facilitate degradation of inhalation anesthetic 18.
In addition, container 12 preferably is constructed of a material that
minimizes the potential for breakage of container 12 during storage,
shipping, and use.
It has been found that containers constructed from a material that contains
polyethylene napthalate provide the desired vapor barrier, chemical
interaction, and strength characteristics when used with inhalation
anesthetics 18. One of ordinary skill will appreciate that there are many
different types of polyethylene napthalate polymers which vary in their
molecular weight, additives, and napthalate content. These polymers can be
categorized into three distinct groups; namely, homopolymers, copolymers
and blends. It has been found that polyethylene napthalate homopolymers
provide higher barriers to vapor transmission when compared to copolymers
and blends. For this reason, it is preferable that the material from which
container 12 of the present invention is constructed contains a
polyethylene napthalate homopolymer. However, it will be appreciated that
certain copolymers and blends of polyethylene napthalate can be used in
connection with the present invention, provided they provide an adequate
barrier to the transmission of vapors, e.g., inhalation anesthetic and
water vapors, therethrough, and provided that they provide the desired
strength and non-reactivity to inhalation anesthetic 18.
In addition to the desirable vapor barrier characteristics of materials
containing polyethylene napthalate, polyethylene napthalate does not
contain Lewis acids and therefore does not pose any threat of facilitating
the degradation of a fluoroether-containing inhalation anesthetic
contained in a container constructed therefrom.
An example of a polyethylene napthalate material useful in connection with
the present invention is HiPERTUF.TM. 90000 polyester resin (trademark of
Shell Chemical Company), a 2,6 dimethyl napthalate based polyethylene
napthalate. One of ordinary skill will appreciate that other polyethylene
napthalates can be used without departing from the scope of the invention
set forth in the appended claims.
In a first embodiment of the present invention, container 12 is constructed
of a single layer of material. That is, container 12 is substantially
homogenous throughout its thickness. In this embodiment, as
above-discussed, container 12 is constructed of a material that contains
polyethylene napthalate.
In an alternative embodiment of the present invention, container 12 is
multi-laminar. As used herein, the term multi-laminar is intended to
include (i) materials constructed of more than one lamina where at least
two of the lamina are constructed of different materials, i.e., materials
that are chemically or structurally different, or materials that have
different performance characteristics, wherein the lamina are bonded to
one another or otherwise aligned with one another so as to form a single
sheet; (ii) materials having a coating of a different material; (iii)
materials having a liner associated therewith, the liner being constructed
of a different material; and (iv) known variations of any of the above. In
this alternative embodiment of the present invention, interior surface 14
of container 12 is preferably constructed of a material containing
polyethylene napthalate. It will be appreciated that the surface of
container 14 in contact with a fluoroether-containing inhalation
anesthetic contained therein will preferably contain polyethylene
napthalate in order to provide the desired vapor barrier characteristics
and simultaneously minimize the likelihood of degradation of the
fluoroether-containing inhalation anesthetic.
In an alternative embodiment of the present invention, container 12 is
constructed of a material containing polymethylpentene. In a preferred
embodiment, a polycyclomethylpentene is used. An example of a
polymethylpentene material useful in connection with the present invention
is "Daikyo Resin CZ" which is manufactured and distributed by the
Daikyo/Pharma-Gummi/West Group. This is a polycyclomethylpentene material.
Alternatively, interior surface 14 of container 12 is constructed of a
material containing polymethylpentene. In this alternative embodiment,
interior surface 14 can be in the form of (i) a liner positioned within a
body defined by a different material, e.g., glass; or (ii) a coating
applied to a body defined by a different material; or (iii) one layer of a
multi-laminar material, as above-discussed with respect to polyethylene
napthalate.
In a second alternative embodiment of the present invention, container 12
is constructed of a material containing one or more of polypropylene,
polyethylene, and ionomeric. Alternatively, interior surface 14 of
container 12 is constructed of a material containing one or more of
polypropylene, polyethylene, and ionomeric resins such as a SURLYN.RTM.
ionomeric resin manufactured by DuPont. As used herein, the term
"ionomeric resin" refers to a thermoplastic polymer that is ionically
cross-linked. In this alternative embodiment, interior surface 14 can be
in the form of (i) a liner positioned within a body defined by a different
material, e.g., glass; or (ii) a coating applied to a body defined by a
different material; or (iii) one layer of a multi-laminar material, as
above-discussed with respect to polyethylene napthalate.
One of ordinary skill in the art will appreciate that a coating can be
applied to an interior surface of container 12 using a variety of known
techniques. The preferred technique will vary dependent upon (i) the
material from which container 12 is made; and (ii) the coating material
being applied to container 12. For example, if container 12 is constructed
of a known glass material, a coating can be applied to the interior
surface of container 12 by heating container 12 to at least the melting
point of the coating material being applied thereto. The coating material
is then applied to the heated container 12 using a variety of known
techniques, e.g., by spraying atomized coating material onto the interior
surface. The container 12 is then allowed to cool to a temperature below
the melting point of the coating material, thereby causing the coating
material to form a single, unbroken film or layer, i.e., interior surface
14.
As depicted in FIG. 1, container 12 defines an opening 20. Opening 20
facilitates the filling of container 12 and provides access to the
contents of container 12, thereby allowing the contents to be removed from
container 12 when they are needed. In the embodiment of the present
invention depicted in FIG. 1, opening 20 is a mouth of a bottle. However,
it will be appreciated that opening 20 can have a variety of known
configurations without departing from the scope of the present invention.
Cap 22 is constructed to seal fluidly opening 20, thereby fluidly sealing
inhalation anesthetic 16 within container 12. Cap 22 can be constructed of
a variety of known materials. However, it is preferable that cap 22 be
constructed of a material that minimizes the transmission of vapor
therethrough and that minimizes the likelihood of degradation of
inhalation anesthetic 16. In a preferred embodiment of the present
invention, cap 22 is constructed from a material containing polyethylene
napthalate. In an alternative embodiment of the present invention, cap 22
has an interior surface 24 that is constructed from a material containing
polyethylene napthalate. In another alternative embodiment of the present
invention, cap 22, and/or interior surface 24 thereof, is constructed of a
material containing polypropylene, polyethylene, and/or ionomeric, the
material having vapor barrier characteristics sufficient to minimize the
transmission of water vapor and inhalation anesthetic vapor therethrough.
In still another alternative embodiment of the present invention, cap 22,
and/or interior surface 24 thereof, is constructed of a material
containing polymethylpentene. In summary, it is to be appreciated that cap
22, and/or interior surface 24 thereof, can be constructed of
polypropylene, polyethylene, polyethylene napthalate, polymethylpentene,
ionomeric resins, and combinations thereof. As above-discussed with
respect to container 12, cap 22 can be homogenous, or may be multi-laminar
in nature.
Cap 22 and container 12 can be constructed such that cap 22 can be
threadingly secured thereto. Containers and caps of this type are well
known. Alternative embodiments of cap 22 and container 12 are also
possible and will be immediately recognized by those of ordinary skill in
the relevant art. Such alternative embodiments include, but are not
necessarily limited to, caps that can be "snap-fit" on containers, caps
that can be adhesively secured to containers, and caps that can be secured
to containers using known mechanical devices, e.g., a ferrule. In the
preferred embodiment of the present invention, cap 22 and container 12 are
configured such that cap 22 can be removed from container 12 without
causing permanent damage to either cap 22 or container 12, thereby
allowing a user to reseal opening 20 with cap 22 after the desired volume
of inhalation anesthetic 18 has been removed form container 12.
Container 12 may include additional features that form no part of the
present invention. For example, container 12 can be configured to include
a system for dispensing inhalation anesthetic 18 from container 12 into an
anesthesia vaporizer. U.S. Pat. No. 5,505,236 to Grabenkort discloses such
a system.
Methods for making containers of the type used in the present invention are
known in the art. For example, it is known that polyethylene napthalate
must be dried to a moisture level of approximately 0.005% prior to
processing in order to yield the optimal physical properties in container
12 and cap 22. A preferred method for making containers 12 and caps 22
useful in connection with the present invention entails the
injection-stretch-blow molding of a material containing polyethylene
napthalate. Machines manufactured by AOKI Technical Laboratory, Inc. of
Tokyo, Japan are particularly useful in performing this molding operation.
The polyethylene napthalate-containing material is injection molded into a
preform which is then transferred to a blow station where it is stretched
and blown to form the container. The container is then batch heated and
annealed in a convective oven.
It has been found that annealing of a material containing polyethylene
napthalate increases the degree of crystallization in the material to a
level not attainable using a blow molding process alone. Increased
crystallization results in a higher barrier to vapor transmission, thereby
enhancing the vapor barrier performance characteristics of a container 12
constructed of an annealed material containing polyethylene napthalate.
Increased crystallization also reduces the overall weight of container 12
(based upon the weight required to attain a selected container strength)
and the amount of material required to achieve a given container strength
for container 12. Increased container strength allows a container to
withstand greater loads during shipping, storage, and use, thereby
minimizing breakage of the container. For example, greater container
strength is desirable when containers 12 are placed one on top of another,
as can occur when containers 12, or cartons or pallets of containers 12,
are stacked for shipping or storage. It should be noted that a container
constructed of a material containing an annealed polyethylene napthalate
weighs less than a glass container having comparable strength
characteristics, is less susceptible to breakage than a glass container of
comparable weight, and costs less to manufacture than a glass container of
comparable performance characteristics. A lower container weight also
reduces the costs associated with shipping such containers. Further, such
a container does not present the potential for degradation of a
fluoroether-containing inhalation anesthetic that is present with a glass
container.
The method of the present invention includes the step of providing a
predetermined volume of a fluoroether-containing inhalation anesthetic 16.
The fluoroether-containing inhalation anesthetic 16 can be one or more of
sevoflurane, enflurane, isoflurane, methoxyflurane, and desflurane. A
container 12 constructed in accordance with the above-described
pharmaceutical product also is provided. In particular, container 12
defines an interior space and is constructed of a material containing
polyethylene napthalate, wherein the polyethylene napthalate is present on
interior surface 14 of container 12, either as a result of the homogenous
material characteristics of container 12, or as a result of interior
surface 14 of a multi-laminar material being constructed of polyethylene
napthalate, as above-discussed. The method of the present invention
further includes the step of placing the predetermined volume of
fluoroether-containing inhalation anesthetic 16 into the interior space
defined by the container.
In an alternative embodiment of the method of the present invention, a
predetermined volume of a fluoroether-containing inhalation anesthetic 16
is provided. The fluoroether-containing inhalation anesthetic 16 can be
one or more of sevoflurane, enflurane, isoflurane, methoxyflurane, and
desflurane. A container 12 constructed in accordance with the
above-described product also is provided. In particular, container 12
defines an interior space and is constructed of a material containing
polymethylpentene, wherein the polymethylpentene is present on interior
surface 14 of container 12, either as a result of the homogenous material
characteristic of container 12, or as a result of interior surface 14 of a
multi-laminar material being constructed of polymethylpentene, as
above-discussed. The method further includes the step of placing the
predetermined volume of fluoroether-containing inhalation anesthetic into
the interior space defined by the container.
In another alternative embodiment of the method of the present invention, a
predetermined volume of a fluoroether-containing inhalation anesthetic 16
is provided. The fluoroether-containing inhalation anesthetic 16 can be
one or more of sevoflurane, enflurane, isoflurane, methoxyflurane, and
desflurane. A container 12 constructed in accordance with the
above-described product also is provided. In particular, container 12
defines an interior space 16 and is constructed of a material containing
one or more of polypropylene, polyethylene, and ionomeric resins, wherein
the recited material(s) is present on interior surface 14 of container 12
either as a result of the homogenous material characteristic of container
12, or as a result of interior surface 14 of a multi-laminar material
being constructed of one of the referenced materials, as above-discussed.
The method further includes the step of placing the predetermined volume
of a fluoroether-containing inhalation anesthetic 16 into the interior
space defined by the container.
It will be appreciated that container 12, and interior surface 14 thereof,
can be constructed of more than one of the above-referenced materials.
In each of the embodiments of the method of the present invention,
container 12 can define an opening 20 therein whereby opening 20 provides
fluid communication between interior space 16 of container 12 and an
external environment of container 12. Each of the embodiments of the
present invention may further include the step of providing a cap 22
constructed of a material containing one or more of: polypropylene,
polyethylene, an ionomeric resin, polyethylene napthalate, and
polymethylpentene. In the alternative, cap 22 can be constructed such that
an interior surface 24 thereof is constructed of a material containing one
or more of: polypropylene, polyethylene, an ionomeric resin, polyethylene
napthalate, and polymethylpentene. The method of the present invention
further includes the step of sealing the opening defined by container 12
with cap 22.
Although the pharmaceutical product and the method of the present invention
have been described herein with respect to certain preferred embodiments,
it will be apparent to one of ordinary skill in the art that various
modifications can be made to the invention without departing from the
spirit and scope of the invention disclosed herein as claimed in the
appended claims.
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